Active Thoracic Compromised Distal LANding in TEvar

NCT06882967 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase

Observational

Started

2022-11-01

Last updated

2025-03-19

Condition(s) studied

Thoracic Aortic AneurysmAortic Diseases

Investigational drug(s) / intervention(s)

Thoracic Endovascular Aortic Repair

Thoracic Endovascular Aortic Repair: Placement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the artery.

Study summary

Thoracic endovascular aortic repair (TEVAR) has become the mainstay of aortic intervention for descending thoracic aortic pathology. Its durability hinges on achieving adequate seal in the endograft landing zones (LZs), with the distal LZ largely understudied. Only recently are suboptimal distal LZs receiving attention for their role in major complications including stent graft migration, type 1B endoleaks, and distal stent graft-induced new entry tears, all of which can contribute to further aortic degeneration. The thoracic distal LZ. When a short distal LZ was reported, the distal endoleak rate ranged from 3.5% to 33%. This led to reintervention in 19%, along with coverage of the celiac trunk in more than half of short LZ cases.

The objective of this study was to evaluate the outcomes of TEVAR patients with compromised distal landing zone (CDLZs) treated with distal active fixation stent-grafts (DAFs), distal scallop stent-grafts, distal Aptus Heli-FX EndoAnchors, and standard stent-grafts.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with descending thoracic aortic aneurysms (DTAAs) with a maximal aortic diameter \> 55mm or rapid growth (\>10mm / year). * Patients presenting with at least 2 cognizable features related to an adverse aortic morphology will be considered for inclusion. The following features will be evaluated for the inclusion: distal LZ length ≤25-mm, distal LZ diameter ≥38-mm, LZ conical morphology, distal descending thoracic aorta angulation ≤116° or tortuosity index ≥1.4 Exclusion Criteria: * Emergency setting, including hemodynamic instability at time of enrollment * Patients with aortic dissection pathology

Primary outcome measure(s)

Ib Endoleak — Follow-up (at month 3)
Presence of type Ib endoleak

Trial sites (1)

Facility	City	Region	Status
Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06882967 on ClinicalTrials.gov ↗ ← All trials in Italy